Effects of Cerebral Protection With Filters vs. Flow Reversal on Cerebral Embolization After Carotid Artery Stenting
Public ClinicalTrials.gov record NCT01414387. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Carotid artery stenting (CAS) with cerebral embolic protection is the preferred treatment for narrowing of the carotid arteries in patients at high risk for open surgery. Special devices are used to protect the brain from particles(emboli) that may break off when the narrowing or blockage is cleared during the angioplasty and stenting procedure. Although filters are most frequently used, protection systems consisting of balloons and flow reversal are also available for cerebral embolic protection. However, there is little information about the effectiveness of filters compared with balloons and flow reversal for prevention of embolization during CAS. The aim of our study is to address this major problem. Our study was designed to answer two specific questions: First, the study will investigate whether balloon-based protection systems are more effective than filters in reducing the amount of particles that break off and travel to the brain during CAS. For this purpose two imaging techniques will be used: magnetic resonance imaging of the brain (MRI), and transcranial doppler (detection of microparticles in the small brain vessels using ultrasound). Second, it will be investigated whether the use of balloon-based protection devices are more effective than filters for prevention of stroke, heart attacks, and death after carotid stenting. The results of the study will provide important information to find out the best way to protect the brain from plaque fragments that may break off during CAS.
Study identification
- NCT ID
- NCT01414387
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 33 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2011
- Primary completion
- Feb 11, 2016
- Completion
- Feb 11, 2016
- Last update posted
- Aug 1, 2017
2011 – 2016
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Dallas VA Medical Center | Dallas | Texas | 75216 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01414387, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 1, 2017 · Synced Sep 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01414387 live on ClinicalTrials.gov.